VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET— 510(k) K053247
Substantially EquivalentMaine Standards Co.
FDA 510(k) clearance K053247 for VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET, Substantially Equivalent on 2006-01-13. Applicant: Maine Standards Co.. Device class: 1.
Clearance details
- Applicant
- Maine Standards Co.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, ME, US
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